UCSF Launches New Phase of Brain Tumor Vaccine Trial

The Brain Tumor Research Center at the University of California, San Francisco has initiated a Phase 2 clinical trial of an investigational vaccine for treating glioma, a recurrent cancer of the central nervous system that occurs primarily in the brain.

The primary objective of the new trial is to evaluate overall survival in patients receiving vitespen vaccination (trademarked as Oncophage).

In an earlier Phase 1 trial of the vaccine, UCSF researchers showed that it was effective in stimulating the patient's immune system to attack tumor cells. Of the 12 patients treated, all showed an immune response.

"We are highly encouraged by the preliminary Phase 1 results in which we observed prolonged overall survival when compared with historical controls, as well as a tumor-specific immune response in all treated patients," said Dr. Andrew Parsa, assistant professor in the UCSF Department of Neurological Surgery and principal investigator of the trial. "Commencement of this Phase 2 trial with Oncophage is an important milestone in the advancement of this novel therapy and represents a potentially important next step in the treatment of this devastating disease."

The Phase 2 trial is designed to enroll approximately 30 patients with recurrent high-grade glioma. Patients will undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines. Eligible patients will be treated after surgery with the vaccine once weekly for four weeks, followed by biweekly injections until vaccine depletion.

Derived from each individual's tumor, the vaccine is designed to program the body's immune system to target cancer cells of that patient. Oncophage has been granted fast track and orphan drug designations from the US Food and Drug Administration in both metastatic melanoma (skin cancer) and renal cell carcinoma (kidney cancer).

Gliomas, also known as primary brain tumors, start in the brain or spinal cord tissue and are always fatal. The American Cancer Society estimates that 20,500 malignant tumors of the brain or spinal cord will be diagnosed during 2007 in the United States, and that about 12,740 people will die from these tumors.

"Sadly, the outcome for primary brain tumors has not changed in more than a decade," Parsa said. "It is our goal to better manage this recurrent cancer so patients not only live longer, but they enjoy an improved quality of life."

The Phase 2 trial is being supported through grants from the American Brain Tumor Association and the National Cancer Institute Special Programs of Research Excellence.

Oncophage is manufactured by Antigenics, a biotechnology company working on development of treatments for cancers and infectious diseases. The company is providing the vaccine for clinical trials.

UCSF is a leading university that consistently defines health care worldwide by conducting advanced biomedical research, educating graduate students in the life sciences, and providing complex patient care.